U.S. patent application number 11/556322 was filed with the patent office on 2007-03-08 for method of measuring the efficacy of a skin treatment program.
Invention is credited to Kelly Huang, Nikiforos Kollias, Ellen Kurtz, Katharine Martin, Florence Natter, Arthur Pellegrino.
Application Number | 20070053940 11/556322 |
Document ID | / |
Family ID | 33298640 |
Filed Date | 2007-03-08 |
United States Patent
Application |
20070053940 |
Kind Code |
A1 |
Huang; Kelly ; et
al. |
March 8, 2007 |
Method of Measuring the Efficacy of a Skin Treatment Program
Abstract
The present invention includes a method of measuring the
efficacy of a skin treatment program on human skin. The method
comprises: a. accessing a multiplicity of photographic images of
human faces, each image having associated with it a chronological
age of the human whose likeness it captures; b. assessing the
multiplicity of photographic images of human faces for a facial
parameter; c. scoring the facial parameter on each image according
to a scoring system to create a parameter score for each image; d.
correlating the parameter scores to the chronological ages to
obtain an age-parameter correlation; e. scoring an untreated
subject human face for the facial parameter to obtain a subject
baseline parameter score; f. treating the subject human face with a
skin treatment program; g. scoring the treated subject human face
for the facial parameter to obtain a subject treatment parameter
score; h. determining the difference between the subject baseline
parameter score and the subject treatment parameter score to obtain
a treatment score difference; and i. comparing the treatment score
difference with the age-parameter correlation to determine a
constructive age change of the human face effected by treatment of
the human face with the skin treatment program.
Inventors: |
Huang; Kelly; (Saint Germain
en Laye, FR) ; Kollias; Nikiforos; (Skillman, NJ)
; Kurtz; Ellen; (Ringoes, NJ) ; Martin;
Katharine; (Ringoes, NJ) ; Natter; Florence;
(Hillsborough, NJ) ; Pellegrino; Arthur; (Newtown,
PA) |
Correspondence
Address: |
PHILIP S. JOHNSON;JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
33298640 |
Appl. No.: |
11/556322 |
Filed: |
November 3, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10421231 |
Apr 23, 2003 |
|
|
|
11556322 |
Nov 3, 2006 |
|
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Current U.S.
Class: |
424/401 |
Current CPC
Class: |
G06T 7/0012 20130101;
A61B 5/0077 20130101; A61B 5/442 20130101; G06T 2207/30004
20130101 |
Class at
Publication: |
424/401 |
International
Class: |
A61K 8/02 20060101
A61K008/02 |
Claims
1. A method of measuring the efficacy of a skin treatment program
on human skin, the method comprising: a. accessing a multiplicity
of photographic images of human faces, each image having associated
with it a chronological age of the human whose likeness it
captures; b. assessing the multiplicity of photographic images of
human faces for a facial parameter; c. scoring the facial parameter
on each image according to a scoring system to create a parameter
score for each image; d. correlating the parameter scores to the
chronological ages to obtain an age-parameter correlation; e.
scoring an untreated subject human face for the facial parameter to
obtain a subject baseline parameter score; f. treating the subject
human face with a skin treatment program; g. scoring the treated
subject human face for the facial parameter to obtain a subject
treatment parameter score; h. determining the difference between
the subject baseline parameter score and the subject treatment
parameter score to obtain a treatment score difference; and i.
comparing the treatment score difference with the age-parameter
correlation to determine a constructive age change of the human
face effected by treatment of the human face with the skin
treatment program.
2. The method of claim 1 wherein the facial parameter is under eye
wrinkles.
3. The method of claim 1 wherein the facial parameter is cheek
wrinkles.
4. The method of claim 1 wherein the facial parameter is crow's
feet wrinkles.
5. A method of measuring the efficacy of a skin care product on
human skin, the method comprising: a. accessing a multiplicity of
photographic images of human faces, each image having associated
with it a chronological age of the human whose likeness it
captures; b. assessing the multiplicity of photographic images of
human faces for a facial parameter; c. scoring the facial parameter
on each image according to a scoring system to create a parameter
score for each image; d. correlating the parameter scores to the
chronological ages to obtain an age-parameter correlation; e.
scoring an untreated subject human face for the facial parameter to
obtain a subject baseline parameter score; f. treating the subject
human face with a skin care product; g. scoring the treated subject
human face for the facial parameter to obtain a subject treatment
parameter score; h. determining the difference between the subject
baseline parameter score and the subject treatment parameter score
to obtain a treatment score difference; and i. comparing the
treatment score difference with the age-parameter correlation to
determine a constructive age change of the human face effected by
treatment of the human face with the skin care product.
6. The method of claim 1 wherein the facial parameter is under eye
wrinkles.
7. The method of claim 1 wherein the facial parameter is cheek
wrinkles.
8. The method of claim 1 wherein the facial parameter is crow's
feet wrinkles.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to a method of measuring the
efficacy of a skin treatment program on human skin.
BACKGROUND OF THE INVENTION
[0002] Humans are generally able to characterize a person to be
within a particular age group based on an image of the person's
face. This characterization may be accomplished by various means,
including the instrumental measurement of age-related changes in
the skin, such as elasticity, cutaneous temperature, replicas, and
water loss. Other techniques involve the clinical grading of
photographs of human subjects by trained professionals to establish
a correlation with skin aging. These trained professionals have
been known to evaluate photographic images for wrinkling on the
forehead, at the eye corners (crow's feet), in the cheekbone area,
and at the mouth corners.
[0003] Computer imaging software is also known for artificially
aging the image of an individual. For instance, such software is
used by some Federal and state law enforcement agencies to age
either a suspect or a victim when a current photograph of that
person is not available. Computer aging has been particularly
useful in cases involving missing children.
[0004] Computer imaging programs have also been useful in allowing
a person to undergo a "virtual makeover", in which virtual "makeup"
is applied to an image of a person or to a composite image created
and displayed by the imaging program. In essence, this method
involves superimposing a mask of various types and colors of makeup
onto an image of a face.
[0005] Plastic surgeons have also used computer imaging to show a
patient how his or her face might be altered as a result of plastic
surgery.
[0006] These skin aging correlations and computer software
programs, however, do not actually measure the effect of the use of
a skin treatment program on a person's skin aging correlation. What
is needed, then, is a method of measuring the efficacy of a skin
treatment program on human skin to determine the constructive age
change of the person's skin by the use of the product.
SUMMARY OF THE INVENTION
[0007] In accordance with the present invention, there has been
provided a method of measuring the efficacy of a skin treatment
program on human skin, the method comprising: [0008] a. accessing a
multiplicity of photographic images of human faces, each image
having associated with it a chronological age of the human whose
likeness it captures; [0009] b. assessing the multiplicity of
photographic images of human faces for a facial parameter; [0010]
c. scoring the facial parameter on each image according to a
scoring system to create a parameter score for each image; [0011]
d. correlating the parameter scores to the chronological ages to
obtain an age-parameter correlation; [0012] e. scoring an untreated
subject human face for the facial parameter to obtain a subject
baseline parameter score; [0013] f. treating the subject human face
with a skin treatment program; [0014] g. scoring the treated
subject human face for the facial parameter to obtain a subject
treatment parameter score; [0015] h. determining the difference
between the subject baseline parameter score and the subject
treatment parameter score to obtain a treatment score difference;
and [0016] i. comparing the treatment score difference with the
age-parameter correlation to determine a constructive age change of
the human face effected by treatment of the human face with the
skin treatment program.
BRIEF DESCRIPTION OF THE FIGURES
[0017] FIG. 1 is a flow chart overview of an embodiment of the
method of the present invention.
[0018] FIG. 2 is a graphical representation of the mean Parameter
Score for each parameter in each age category.
DETAILED DESCRIPTION OF THE INVENTION
[0019] The present invention relates to a method of measuring the
efficacy of a skin treatment program on human skin. More
specifically, as shown in the embodiment of FIG. 1, the present
invention relates to first accessing a multiplicity of photographic
images 10 of human faces 12, each image having associated with it a
chronological age 14 of the human whose likeness it captures. Each
of the multiplicity of photographic images is assessed 16 for a
certain facial parameter and scored according to a scoring system
to create a parameter score 18 for each image. The parameter scores
of the images are then correlated to the chronological ages to
obtain an age-parameter correlation 20. An untreated subject human
face 30 is then scored 32 by the same scoring system for the facial
parameter to obtain a subject baseline parameter score 34. The
subject human face is then treated with a skin care product 38, and
the treated subject human face 40 is subsequently scored 42 by the
same scoring system for the facial parameter to obtain a subject
treatment parameter score 44. The difference between the subject
baseline parameter score and the subject treatment parameter score
is determined to obtain a treatment score difference 50. The
treatment score difference 50 is then compared with the
age-parameter correlation 20 to determine a constructive age change
60 of the human face effected by treatment of the subject human
face with the skin care product.
[0020] According to the present invention, a method is provided for
measuring the efficacy of a skin treatment program on human skin.
More specifically, the method provides a method for measuring the
efficacy of an anti-aging skin treatment program in terms of the
constructive age change, or apparent age change, of human skin
after the use of the treatment program. As used herein,
constructive age change means the apparent change in the age of a
human due to changes in certain parameters of the human's skin that
cause the human's skin to appear younger. The terminology "skin
treatment program" refers to any skin care regimen that is intended
to have a noticeable effect on human facial appearance and
includes, but is not limited to nutritional programs, the use of
topical skin care products, the use of skin care devices, oral
dosage forms, massage therapy, radiation treatments, and the like
and combinations thereof.
[0021] The method of the present invention involves accessing a
multiplicity of photographic images of human faces with each image
having associated with it a chronological age of the human whose
likeness it captures. Photographic images include any conventional
media capable of capturing the image of a human subject such as
digital or analog electronic cameras as well as conventional film
based photographic techniques. The images may be created with any
type of light that is capable of capturing a chronological age
related feature of a human subject, including but not limited to
visible, infrared, ultra-violet, fluorescent, parallel polarized
light and the like. The images may be captured and stored in
electronic form or in the form of printed photographic images or in
any other form in which the images may be visualized accurately.
Preferably, the multiplicity of images are obtained from a
multiplicity of humans of racial background and gender that are
similar to the human subject being evaluated, and across a range of
ages, preferably including ages that are less than and greater than
the human subject. It is also preferable that the multiplicity of
humans be of a sufficient number to provide statistical
significance.
[0022] The images are then assessed for at least one facial
parameter that changes as a human ages, including without
limitation, eye corner wrinkles (crow's feet), cheek wrinkles,
forehead wrinkles, under-eye wrinkles, nasolabial folds, frown
lines, mottled hyper-pigmentation, redness, and the like and
combinations thereof. The assessment of the facial parameters may
be done by objective measurement, including measurement by an
instrument, or by subjective measurement, such as by grading or
scoring according to a predefined scale by a trained expert to
obtain at least one parameter score for each image.
[0023] The parameter scores are then correlated to the
chronological ages of the respective humans from which each image
was obtained to obtain an age parameter correlation. This age
parameter correlation provides information about which parameters
exist with a certain frequency or severity in humans at particular
chronological ages.
[0024] An untreated subject human face or an image of an untreated
subject human face is scored for facial parameters according to the
same method used to score the facial parameters of the multiplicity
of photographic images to obtain a subject baseline parameter
score. The subject is then treated with a skin treatment program,
preferably with a skin care product, which may include without
limitation, a lotion, a cream, a cleanser, a gel, a liquid, a
powder, a toner, an astringent, and combinations thereof.
Preferably, the skin care product is an anti-aging topical skin
treatment product. After the subject skin has been treated with the
product for a given length of time, the treated subject human face
or an image of the treated subject human face is scored for facial
parameters according to the same method used previously to score
the untreated human face to obtain a subject treatment parameter
score.
[0025] The difference between the subject treatment parameter score
and the subject baseline parameter score is determined to obtain a
treatment score difference. The treatment score difference is
compared with the age parameter correlation to determine the
constructive age change of the subject human face effected by the
treatment of the human face with the skin treatment program.
[0026] The constructive age change of the subject human face is a
measure of the efficacy of the skin treatment program on human skin
and is useful in communicating the effectiveness of the skin
treatment program to potential users of the product.
EXAMPLE
Image Assessment Study
[0027] Images (including visible and polarized images) of 421
Caucasian women ranging in age from 20-79 years were obtained. The
images were obtained by taking a photograph using polarized light
and a standard photograph of each subject. A "standard photograph",
as used herein, refers to a photograph that is taken of the subject
using visible light (e.g., light having a wavelength from about 400
to about 700 nm).
Visible Light Photography
[0028] The standard photograph was obtained by illuminating the
subject with two flash units that emitted visible light. The flash
units were further equipped with a diffusing filter that was placed
in front of each flash unit. A diffusing filter is a filter, which
assists in uniformly dispersing light (e.g., to help eliminate "hot
spots"). Examples of such diffusing filters include, but are not
limited to, frosted glass filters such as a Broncolor Diffuser
(Sinar Bron, Allschwil, Switzerland), metal grids which may be
printed on glass substrates, or a diffusing reflective umbrella for
indirect lighting.
[0029] The flash units were angled at the subject's skin to
generate a gradient across the surface of the skin. Additionally,
the flash units were mounted higher than the skin area of the
subject and aimed at such skin area in order to give a gradient of
light on the skin from the top to the bottom. The angle of the
flash units was approximately 10 degrees from horizontal. This
gradient visually enhanced various features of the skin such as the
fine lines and wrinkles in the subject, e.g., the crow's feet
around the eye and forehead or mouth area wrinkles.
Polarized Light Photography.
[0030] A polarized photograph was also taken of each subject. A
"polarized photograph", as used herein, refers to a photograph of
the subject taken with a light source that emits light through a
polarizing filter.
[0031] The camera and two flash units were on about the same plane
as the subject's skin to be photographed, and the flash units were
placed so that the angle formed by the flash units, the subject's
skin, and the camera was about 45 degrees. A polarizing filter was
placed in front of each flash unit. As used herein, a "polarizing
filter" is a filter that filters incoming light to emit
substantially only polarized light. As used herein, the term
"substantially," means at least 75 percent, preferably 90 percent,
and most preferably at least 95 percent.
[0032] Examples of a polarizing filter include, but are not limited
to, polarizing plates such as those available from Edmund
Scientific (Barrington, N.J. USA), polarizing prisms such as Glan
Thomson polarizing prisms, or a polarizing reflector that reflects
light at about the Brewster angle.
[0033] A linear polarizing filter was used at the light source and
the linear polarizing filter was arranged such that the electric
field of the emitted light was about perpendicular to the plane
formed by the light source, the person's skin, and the camera. The
resulting image had a high degree of glare, which was further
enhanced when an optical coupling medium, such as sebum or "oils,"
was present on the surface of the skin. The polarized image,
thereby, allows an estimate to be made as to the oiliness of the
subject's skin. It also provides insight into the number and
severity of pores on the cheek and forehead areas of the facial
skin. Other desired outcomes of polarized photography include, but
are not limited to, an enhanced image of surface features such as
fine lines, skin texture, scales and vellous hair.
[0034] The images were randomized and evaluated by a trained
clinical grader for six age-related parameters: under-eye wrinkles,
crow's feet, forehead wrinkles, frown lines, nasolabial folds, and
cheek wrinkles. The grader was blinded to the chronological ages of
the subjects of whom the images were taken. The grader scored each
parameter on a 10-point ordinal scale with the following ratings:
0=none; 1-3=mild; 4-6=moderate; 7-9=severe. The objective of this
portion of the study was to correlate the parameter score variables
with age.
[0035] FIG. 2 is a graphical representation of the mean parameter
score for each parameter in each age category.
[0036] The Mantel-Haenszel correlation statistic tests the null
hypothesis of no association against the alternative of linear
association in at least one age stratum. A p-value of 0.05 was used
to declare statistical significance, and SAS version 8.2
statistical software (Cary, N.C.) was used for all statistical
analyses.
[0037] Among the 421 women whose images were scored, the mean age
was 38.1 years (standard deviation (SD) 13.4, median 35.0), and
ranged from 20 to 79 years. The percentage of women aged 20-29,
30-39, 4-49, 50-59, 60-69, and .gtoreq.70 years was 31%, 28%, 21%,
13%, 6%, and 2% respectively.
[0038] Table 1 presents the number and percentage of women with
ratings of none, mild, moderate, and severe for each decade of age.
For each parameter, the distribution of rating shifts towards
greater severity corresponding to greater age. The p-value was
statistically significant for each of the parameters (P<0.0001),
indicating a strong linear association of age and parameter scores.
TABLE-US-00001 TABLE 1 20-29 Yr. 30-39 Yr. 40-49 Yr. 50-59 Yr.
60-69 Yr. 70+ Yr. Crow's Feet 0.38 1.22 3.05 3.89 4.56 5.78 Under
Eye Wrinkles 0.82 1.87 3.17 3.77 3.92 5.22 Cheek Wrinkles 0.06 0.25
0.95 1.23 3.04 4.89 Nasolabial Fold 0.42 1.14 2.67 3.42 4.52 5.33
Forehead Wrinkles 0.69 1.47 2.53 1.94 1.96 3.56 Frown Lines 0.17
0.61 1.71 2.15 3.72 4.22
[0039] As seen in Table 2, using Spearman correlation coefficients,
age was positively correlated with each of the parameters, and was
greatest for crow's feet (r=0.791), under-eye wrinkles (r=0.774)
and nasolabial folds (r=0.774). The pairwise correlations among the
parameters indicated positive associations also. TABLE-US-00002
TABLE 2 Spearman Correlation Under- Crow's Eye Cheek Nasolabial
Forehead Frown Age Feet Wrinkles Wrinkles Folds Wrinkles Lines Age
1.000 0.791 0.774 0.544 0.774 0.429 0.629 Crow's 1.000 0.840 0.564
0.775 0.472 0.583 Feet Under-Eye 1.000 0.569 0.720 0.505 0.610
Wrinkles Cheek 1.000 0.536 0.314 0.522 Wrinkles Nasolabial 1.000
0.424 0.523 Folds Forehead 1.000 0.338 Wrinkles Frown 1.000
Lines
Treatment Study
[0040] Twenty five women subjects participated in a randomized,
placebo-controlled, single-center, within-subject comparison
treatment study. The women who were selected for the study had
moderate to severe photodamaged facial skin. A trained clinical
grader rated each of the women for facial parameters at the
beginning of the study or baseline to determine a baseline
parameter score, after 1 month, after 2 months, and after 3 months
to determine a treatment parameter score. The parameters that were
rated were under-eye wrinkles, crow's feet, nasolabial folds, and
cheek wrinkles. The rating system involved using the same trained
clinical grader as in the grading of the images described
hereinbefore, and involved using the same scoring scale as that
used to determine the age parameter correlation as described
above.
[0041] During the study, each woman subject treated the skin on one
half of her face with a skin care product formulation for treating
aging parameters and the skin on the other half of her face with a
placebo formulation. Each subject treated her facial skin in this
way twice daily for the duration of the study, using the same
formulation on the same half of her face. Neither the subjects nor
the grader knew which formulation was the skin care product
formulation or which was the placebo formulation, or in other
words, the study was double-blind.
[0042] The composition of the formulation was as follows.
TABLE-US-00003 Ingredient CTFA name Function % wt/wt Lipid Phase
Arlacel 165 Glyceryl Stearate & PEG-100 Stearate emulsifier
3.8000 Brij 76 Steareth-10 emulsifier 1.4000 Procol ST 20G
Ceteareth 20 and Stearyl Alcohol emulsifier 3.0000 Procol CS 20D
Ceteareth 20 and Cetearyl Alcohol emulsifier 3.0000 Wickenol 171
Octyl Hydroxystearate emollient 5.8000 Tween 80 Polysorbate 80
emulsifier 0.7000 Stearyl Alcohol Stearyl alcohol emollient 0.5000
Vitamin A alcohol blend Retinol 50C in Polysorbate 20 skin
conditioner 0.2700 BHT Butylated hydroxytoluene antioxidant 0.1000
Water Phase DI Water Water vehicle 64.1700 Sepitonic M3 Mg
Aspartate & Zn gluconate & Cu Gluconate Skin conditioner
1.0000 Disodium EDTA Disodium EDTA chelator 0.1000 Glycerin
Glycerin humectant 4.0000 Keltrol CG-BT Xanthan Gum Thickener
0.3000 Methylparaben Methylparaben preservative 0.2500
Propylparaben Propylparaben preservative 0.1500 Post Additions
Emeressence 1160 Phenoxyethanol preservative 0.7300 Dimethicone 47V
Dimethicone, 100 cst skin conditioner 2.5000 Actiquench butylene
glycol, water, camellia oleifera extract antioxidant 0.1000 Calcium
D-Pantothenate Calcium D-Pantothenate antioxidant 0.0500 Erythrobic
Acid Isoascorbic Acid antioxidant 0.0500 Simulgel NS Hydroxyethyl
acrylate/Sodium thickener 1.5000 acryloyldimethyltaurate and
squalane and polysorbate 60 DMAE Dimethylaminoethanol skin
conditioner 2.5000 Buffer Premix DI water DI water solvent 1.5800
Malic Acid Malic Acid pH adjuster 1.0100 Glypure Glycolic Acid, 70%
pH adjuster 1.4400 TOTAL 100.0000
[0043] The formulation was prepared according to the following
process: TABLE-US-00004 Batch Process Oil Phase 1. Heat kettle to
70.degree. C. +/- 10.degree. C. and add Arlacel, Brij, Procols,
Stearyl Alcohol. Mix until uniform. 2. Cool to 65.degree. C. +/-
5.degree. C., add BHT, Wickenol, and Tween 80. Hold at 65.degree.
C. +/- 5.degree. C. for phasing. 3. Blanket lipid tank with argon,
turn on yellow lights and add retinol just prior to phasing. Water
Phase 4. Add Water to beaker. Bubble argon through until dissolved
oxygen <2 ppm. 5. Blanket water phase with argon. 6. Premix
glycerin and xanthan and add to batch, mix well and begin heating.
Add EDTA and Sepitonic M3. 7. At 80.degree. C. +/- 5.degree. C.,
add Methyl and Propyl paraben. Mix until dissolved. 8. Cool to
65.degree. C. +/- 5.degree. C. and hold for phasing. Phasing 9. Add
Oil phase (60.degree. C.-70.degree. C.) to water phase (60.degree.
C.-70.degree. C.) with rapid mixing. Maintain argon blanket.
Finishing 8. At 65.degree. C. or below (45.degree. C.-65.degree.
C.) Add simulgel and mix until uniform. Begin cooling batch. 9.
Below 50.degree. C., and Emeressence, Dimethicone, Actiquench,
Calcium D-Pantothenate, and Erythorbic acid. 10. Below 40.degree.
C., add DMAE, adjust pH to 6 (5.6-6.3) with water/malic/glypure
premix. 11. QS with water.
[0044] The composition of the placebo formulation was the same as
that of the skin care formulation, except that the
dimethylaminoethanol (DMAE) and the retinol were omitted.
[0045] The estimated change in parameter score for each 10-year
change in age in the subset of women aged 38 to 57 was computed for
the image assessment study of the 421 women described above. These
parameter score changes were compared to parameter score changes
observed among the women in the product study. These changes were
defined as 10 times the mean change of the product study divided by
the 10-year change in the parameter score from the image assessment
study, which provided the proportionate reduction in years, or
constructive age reduction. As shown in Table 3, the constructive
age reduction following active treatment with the skin care product
for 3 months was 13.2 years (95% Confidence Interval: 7.3 to 19.3)
for under-eye wrinkles, 7.2 years (95% Confidence Interval: 4.5 to
10.0) for crow's feet, 0.8 years (95% Confidence Interval: 0.3 year
increase to 2.0 year decrease) for nasolabial folds, and 12.3 years
(95% Confidence Interval: 7.2 to 15.2) for cheek wrinkles.
TABLE-US-00005 TABLE 3 Mean 95% CI 10-yr. Constructive 95% CI
Parameter Change Lower Upper Change Age Reduction Lower Upper
Under-eye -0.60 -0.33 -0.87 0.45 13.2 years 7.3 19.3 wrinkles
Crow's -0.68 -0.42 -0.94 0.94 7.2 years 4.5 10.0 feet Nasolabial
-0.08 +0.03 -0.19 0.97 0.8 Years -0.3 2.0 Fold Cheek -1.08 -0.82
-1.34 0.88 12.3 years 7.2 15.2 Wrinkles
[0046] The specification and example above are presented to aid in
the complete and non-limiting understanding of the invention
disclosed herein. Since many variations and embodiments of the
invention can be made without departing from its spirit and scope,
the invention resides in the claims hereinafter appended.
* * * * *